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Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
two-generation reproductive toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Reproductive effects observed:
not specified
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

This endpoint is waived due to the very low toxicity potential of triethyl citrate.


Short description of key information:
This endpoint is waived due to the very low toxicity potential of triethyl citrate.

Justification for selection of Effect on fertility via oral route:
Based on the available toxicity data for the substance and its structural analogues, adverse effects concerning toxicity to reproduction are not to be expected and therefore no further study is needed.

Justification for selection of Effect on fertility via inhalation route:
Inhalation is not a relevant route of exposure. Further, based on the available toxicity data for the substance and its structural analogues, adverse effects concerning toxicity to reproduction are not to be expected and therefore no further study is needed.

Justification for selection of Effect on fertility via dermal route:
Based on the available toxicity data for the substance and its structural analogues, adverse effects concerning toxicity to reproduction are not to be expected and therefore no further study is needed.

Effects on developmental toxicity

Description of key information
1) From a 12-months oral study with cross over mating after 9 months in rats NOEL values for maternal toxicity and developmental toxicity were given with 50 and 250 mg/kg, respectively (Larionov AG & Cherkasova TE, 1977). [Read-across data from tributyl-O-acetylcitrate (CAS 77-90-7)]
2) From a 12-months oral study with cross over mating after 9 months in mice NOEL values for maternal toxicity and developmental toxicity were given with 50 and 250 mg/kg, respectively (Larionov AG & Cherkasova TE, 1977). [Read-across data from tributyl-O-acetylcitrate (CAS 77-90-7)]
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
250 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
good quality
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Development toxicity / teratogenicity

A Toxicological evaluation of Acetyltributylcitrate [Larionov & Cherkasova, 1977; cited in US EPA (2004) HPV Chemicals Challenge Program] has been carried out as follows: Groups of rats and mice were dosed with a milk solution of ATBC via diet at nominal doses of 50 and 250 mg/kg over 12 months. A cross-mating of the animals was performed. In the 9th month of the study, gonads were evaluated and the animals were evaluated for embryotoxic effects. The dosing caused no significant effects on male sexual cells, no embryotoxic effects and there also were no adverse effects on growth and foetal/litter development in the offspring. The NOEL values for maternal toxicity and developmental toxicity were given with 50 and 250 mg/kg, respectively. It can be assumed that the same applies to triethyl citrate (CAS 77-93-0) as it is a near analogue to the test substance acetyl tributyl citrate.


Justification for selection of Effect on developmental toxicity: via oral route:
Acceptable well documented publication which meets basic scientific principles (structural analogue ATBC).

Justification for selection of Effect on developmental toxicity: via inhalation route:
Inhalation is not a relevant route of exposure. No further studies are needed.

Justification for selection of Effect on developmental toxicity: via dermal route:
No further studies are needed. The feeding developmental study in rats is sufficient to cover possible effects after dermal exposure.

Justification for classification or non-classification

Developmental toxicity was not observed at dose levels up to 1000 mg/kg/day in a two-generation reproductive toxicity study nor in a 13-week toxicity study with an in utero exposure phase. The metabolites positively identified in the urine of rats have been demonstrated to undergo rapid clearance from the body and are not suspected to be developmental toxicants. Also several long-term studies gave no indications for adverse effects on reproductive organs. Therefore, there is no need for classification of ATBC. As the substance 'triethyl citrate' (CAS 77-93-0) is a near analogue to ATBC it can be considered to be also not classified.